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    Summary
    EudraCT Number:2013-002192-18
    Sponsor's Protocol Code Number:TRIO020
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-09-26
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2013-002192-18
    A.3Full title of the trial
    A randomized open-label Phase II study of letrozole plus afatinib (BIBW2992) versus letrozole alone in first-line treatment of advanced ER+, HER2- postmenopausal breast cancer with low ER expression
    ?ESTUDIO FASE II ABIERTO ALEATORIZADO DE LETROZOL MÁS AFATINIB (BIBW2992) FRENTE A LETROZOL SOLO EN EL TRATAMIENTO DE PRIMERA LÍNEA DEL CÁNCER DE MAMA AVANZADO EN PACIENTES POSTMENOPÁUSICAS RE+, HER2- CON BAJA EXPRESIÓN DE RE?.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An unblinded clinical trial for the treatment of a particular subtype of postmenopausal breast cancer where the patient will receive at random either Afatinib plus Letrozole or Letrozole alone
    Ensayo clínico para el tratamiento de pacientes postmenopáusicas con un subtipo particular de cáncer de mama en el que las pacientes podrán recibir (mediante asignación al azar) Afatinib más Letrozol o Letrozol solo.
    A.4.1Sponsor's protocol code numberTRIO020
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorTranslational Research In Oncology
    B.1.3.4CountryCanada
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBoehringer Ingelheim GmBH
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTranslational Research In Oncology
    B.5.2Functional name of contact pointProject Management
    B.5.3 Address:
    B.5.3.1Street Address11, rue Watt
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75013
    B.5.3.4CountryFrance
    B.5.4Telephone number+33 1 58 10 09 09
    B.5.5Fax number+33 1 58 10 09 10
    B.5.6E-mailTRIO020.contact@trioncology.org
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAfatinib
    D.3.2Product code BIBW2992
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAfatinib
    D.3.9.1CAS number 850140-73-7
    D.3.9.2Current sponsor codeBIBW2992
    D.3.9.3Other descriptive nameAFATINIB DIMALEATE
    D.3.9.4EV Substance CodeSUB121316
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAfatinib
    D.3.2Product code BIBW2992
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAfatinib
    D.3.9.1CAS number 850140-73-7
    D.3.9.2Current sponsor codeBIBW2992
    D.3.9.3Other descriptive nameAFATINIB DIMALEATE
    D.3.9.4EV Substance CodeSUB121316
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Advanced ER+, HER2- postmenopausal breast cancer with low ER expression
    Pacientes postmenopáusicas con cáncer de mama avanzado RE+, Her- con baja expresión de RE.
    E.1.1.1Medical condition in easily understood language
    Breast cancer
    Cáncer de mama
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the effect of letrozole plus afatinib and of letrozole alone on progression-free survival (PFS) in the first line treatment of ER+, HER2 negative postmenopausal ABC women with low ER expression.
    Evaluar el efecto de letrozol más afatinib y de letrozol solo en la supervivencia libre de progresión (SLP) en el tratamiento de primera línea de mujeres posmenopáusicas con CMA RE+, HER2 negativo y con baja expresión de RE.
    E.2.2Secondary objectives of the trial
    To assess secondary measures of efficacy for afatinib administered in combination with letrozole and for letrozole alone (Overall survival - Objective Response rate - Time to tumor progression).

    To assess the safety and tolerability of afatinib administered in combination with letrozole and of letrozole alone (Overall safety profile).
    Evaluar medidas secundarias de eficacia para afatinib administrado en combinación con letrozol y para letrozol solo.
    Criterios de valoración:
    -Supervivencia global (SG)
    -Tasa de respuesta objetiva (TRO)
    -Tiempo a la progresión tumoral (TP)
    Evaluar la seguridad y tolerabilidad de afatinib administrado en combinación con letrozol y de letrozol solo.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Optional Pharmacogenomic study - TRIO 020 Protocol - version 1.0 - 19 Feb 2013.
    Examination of the molecular profiles of tumor tissue submitted by the subjects to identify factors that may influence biological and clinical responses to Afatinib and Letrozole including but not limited to ER and PR H-score and the EGFR related downstream pathways.

    As more development and information is revealed in the future, the tumor samples will be stored in the sponsor central laboratory until future use is required. Tumor tissue provided for central determination of ER/PR and HER2 statuses will be used to perform this additional research for subjects having given their consent. No additional sample will be required. If subject refuses to participate in the optional sub-study then tumor tissue will only be assessed for determination of ER/PR and HER2 statuses to assess subject's eligibility in the study.
    E.3Principal inclusion criteria
    1.Signed and dated informed consent document indicating that the subject (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment.
    2.Postmenopausal female, 18 years of age or older.
    Postmenopausal status defined as:
    oPrior bilateral surgical oophorectomy or
    oAmenorrhea and age ? 60 years or
    oAge < 60 years and amenorrhea for 12 or more months and FSH and estradiol in the postmenopausal ranges
    3.Histologically or cytologically proven diagnosis of adenocarcinoma of the breast with evidence of locally recurrent disease not amenable to resection or radiation therapy with curative intent, or metastatic disease.
    4.HER2 negative breast cancer. Local testing should demonstrate that the tumor is 0 or 1+ by immunohistochemistry (IHC) or is considered to be HER2 negative for gene amplification by fluorescence in-situ hybridization (FISH), chromogenic in-situ hybridization (CISH) or other in-situ hybridization (ISH) method. Central testing (required for all subjects) must demonstrate that the tumor is HER2 negative by FISH or IHC.
    5.ER positive breast cancer. Local testing should demonstrate that the tumor is ER positive. Central testing (required for all subjects) must demonstrate that the tumor is ER+, low amplification (H-score < 160).
    6.Paraffin-embedded tumor block(s) available for centralized assessment of ER, PR, and HER2. If no tumor block is available, 15 to 20 unstained slides of paraffin-embedded tissue from the tumor obtained at the initial diagnosis or prior biopsy or surgery (archived tumor tissue) will be accepted. Slides must be positively charged, frosted-end. Tumor biopsies may be from either the primary or metastatic site of disease.
    When tumor tissue from the primary tumor and from metastatic sites is available, the sample from the most recent biopsy/surgery/procedure will be sent to Central laboratory.
    7.Measurable disease according to RECIST 1.1 (E.A. Eisenhauer 2009) or bone-only non measurable disease according to RECIST 1.1. Previously irradiated lesions are deemed measurable only if progression is documented at the site after completion of radiation.
    8.Eastern Cooperative Oncology Group (ECOG) Performance status 0 or 1.
    9.Adequate organ function as defined by the following criteria:
    -Hemoglobin ? 9 g/dL
    -Absolute neutrophils count (ANC) ? 1.2 x 109/L
    -Platelets ? 100 x 109/L
    -Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ? 3 x upper limit of normal (ULN), or AST and ALT ? 5 x ULN if liver function abnormalities are due to liver metastasis.
    -Total serum Bilirubin ? 1.5 mg/dL (? 26 µ mol/L) regardless of liver involvement secondary to tumor. Inclusion of subjects with increased serum indirect bilirubin due to Gilbert?s syndrome is permitted.
    -Serum creatinine ? 1.5 x ULN. For subjects with serum creatinine > 1.5 x ULN then calculated (Cockcroft-Gault formula) or measured Creatinine clearance ? 60 mL/min is required.
    10.Baseline resting left ventricular ejection fraction (LVEF) ? 50% measured by multigated acquisition scan (MUGA scan) or echocardiogram.
    11.Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.
    1.Consentimiento informado firmado y fechado que indica que la paciente (o su representante legal) ha sido informada de todos los aspectos pertinentes del ensayo antes de su inclusión.
    2.Mujer posmenopáusica ? 18 años.
    Estado posmenopáusico definido como:
    Ooforectomía quirúrgica bilateral previa o
    Amenorrea y edad ? 60 años o
    Edad < 60 años y amenorrea ? 12 meses y FSH y estradiol dentro de los rangos posmenopáusicos
    3.Diagnóstico de adenocarcinoma de mama confirmado histológica o citológicamente con evidencia de enfermedad localmente recurrente no susceptible de resección o radioterapia con intención curativa, o enfermedad metastásica.
    4.Cáncer de mama HER2 negativo. Las determinaciones locales deberán demostrar que el tumor es 0 ó 1+ por inmunohistoquímica (IHQ) o considerado HER2 negativo por amplificación génica analizada por hibridación fluorescente in situ (FISH), hibridación cromogénica in situ (CISH) u otro método de hibridación in situ (ISH). Las determinaciones centrales (necesarias para todas las pacientes) deben demostrar que el tumor es HER2 negativo por FISH o IHQ.
    5.Cáncer de mama RE positivo. Las determinaciones locales deberán demostrar que el tumor es RE positivo. Las determinaciones centrales (necesarias para todas las pacientes) deben demostrar que el tumor es RE+ con baja amplificación (H-score < 160).
    6.Disponibilidad de bloque(s) de tumor embebido(s) en parafina para la evaluación centralizada de RE, RPg y HER2. Si no se dispone de bloques de tumor, se aceptarán de 15 a 20 laminillas no teñidas de tejido embebido en parafina del tumor obtenido en el diagnóstico inicial o en una biopsia o cirugía previa (tejido tumoral archivado). Las laminillas deben estar cargados positivamente y con un extremo esmerilado Las biopsias del tumor pueden ser tanto de la localización primaria como de una lesión metastásica de la enfermedad.
    Cuando se disponga de tejido tumoral del tumor primario y de localizaciones metastásicas, se enviará al laboratorio central la muestra de la biopsia/cirugía/procedimiento más reciente.
    7.Enfermedad medible de acuerdo con RECIST 1.1 (E.A. Eisenhauer 2009) o sólo enfermedad ósea no medible de acuerdo con RECIST 1.1. Las lesiones irradiadas previamente sólo se consideran medibles si se documenta la progresión después de la finalización de la radioterapia.
    8.Estado funcional del Eastern Cooperative Oncology Group (ECOG) de 0 ó 1 (APÉNDICE 1).
    9.Adecuada función orgánica definida según los siguientes criterios:
    -Hemoglobina ? 9 g/dL
    -Recuento absoluto de neutrófilos (RAN) ? 1,2 x 109/L
    -Plaquetas ? 100 x 109/L
    -Aspartato transaminasa sérica (AST) y alanina aminotransferasa sérica (ALT) ? 3 x límite superior normal (LSN), o AST y ALT ? 5 x LSN si las anormalidades de la función hepática son debidas a metástasis en el hígado.
    -Bilirrubina sérica total ? 1,5 mg/dL (? 26 µmol/L) independientemente de la afectación hepática secundaria al tumor. Se permite la inclusión de pacientes con la bilirrubina indirecta sérica aumentada debido al síndrome de Gilbert.
    -Creatinina sérica ? 1,5 x LSN. Para las pacientes con creatinina sérica > 1,5 x LSN es necesario un aclaramiento de creatinina calculado (fórmula de Cockcroft-Gault) o medido ? 60 mL/min.
    10.Fracción de eyección del ventrículo izquierdo (FEVI) basal en reposo ? 50% medida por ventriculografía isotópica (MUGA) o ecocardiograma.
    11.Disposición y capacidad para cumplir las visitas programadas, el plan de tratamiento, las pruebas de laboratorio y otros procedimientos del ensayo.
    E.4Principal exclusion criteria
    1.Brain metastases (even if treated and/or stable), spinal cord compression, carcinomatous meningitis, or leptomeningeal disease.
    2.Prior treatment with any type of systemic therapy for locally-recurrent disease not amenable to resection or radiation therapy with curative intent, or for metastatic disease.
    3.Prior treatment with letrozole in (neo)adjuvant setting with disease-free interval ? 12 months from completion of treatment until randomization.
    4.Prior treatment with any anti HER-family targeted therapy in (neo)adjuvant setting.
    5.Any concurrent or previous malignancy within 5 years prior to randomization except for adequately and radically treated basal or squamous skin cancer, or carcinoma in situ of the cervix, or other non-invasive/in-situ neoplasm. A subject with previous history of invasive malignancy (other than adequately and radically treated basal or squamous skin cancer) is eligible provided that she has been disease free for more than 5 years.
    6.Non-measurable disease according to RECIST 1.1 (E.A. Eisenhauer 2009), with the exception of bone-only non-measurable disease.
    7.Known pre-existing interstitial lung disease.
    8.Significant or recent acute gastrointestinal disorders with diarrhea as a major symptom e.g. Crohn's disease, malabsorption or CTCAE v4.0 grade ? 2 diarrhea of any aetiology.
    9.History or presence of clinically relevant cardiovascular abnormalities, as per investigator assessment such as uncontrolled hypertension, congestive heart failure NYHA Class ? III, unstable angina or poorly controlled arrhythmia. Myocardial infarction within 6 months prior to randomization.
    10.Any other concomitant serious illness or organ system dysfunction which in the opinion of the investigator would either compromise subject safety or interfere with the evaluation of the safety of the test drug.
    11.Any contraindication to oral agents.
    12.Active hepatitis B infection (defined as presence of Hep B sAg and/or Hep B DNA), active hepatitis C infection (defined as presence of Hep C RNA) or known HIV carrier.
    13.Known or suspected active drug or alcohol abuse.
    14.Known hypersensitivity to afatinib or letrozole or the excipients of any of the trial drugs.
    15.Concomitant treatment with strong inhibitor of P-gp.
    16.Any ongoing acute clinically significant toxic effect of prior anticancer therapy or any persisting complication of prior surgery.
    1.Metástasis cerebrales (incluso si están siendo tratadas y/o son estables), compresión de la médula espinal, meningitis carcinomatosa o enfermedad leptomeníngea.
    2.Tratamiento previo con cualquier tipo de terapia sistémica para la enfermedad localmente recurrente no susceptible de resección o radioterapia con intención curativa, o para la enfermedad metastásica.
    3.Tratamiento previo con letrozol en el contexto (neo)adyuvante con un intervalo libre de enfermedad ? 12 meses desde la finalización del tratamiento hasta la aleatorización.
    4.Tratamiento previo con cualquier terapia dirigida anti-HER en el contexto (neo)adyuvante.
    5.Cualquier tumor maligno concurrente o previo en los 5 años anteriores a la aleatorización, con excepción del carcinoma de células basales o escamosas de la piel, el carcinoma in situ de cérvix u otras neoplasias no infiltrantes/in situ, tratados de forma adecuada y radical. Una paciente con antecedentes de tumor maligno infiltrante (que no sea el cáncer de células basales o escamosas de la piel adecuada y radicalmente tratada) es elegible siempre y cuando haya estado libre de enfermedad durante más de 5 años.
    6.Enfermedad no medible según RECIST 1.1 (E.A. Eisenhauer 2009), con excepción de sólo enfermedad ósea no medible.
    7.Enfermedad pulmonar intersticial preexistente conocida.
    8.Trastornos agudos gastrointestinales significativos o recientes con diarrea como síntoma principal, p. ej. enfermedad de Crohn, malabsorción o diarrea de grado ? 2 según CTCAE v4.0 de cualquier etiología.
    9.Antecedentes o presencia de anormalidades cardiovasculares clínicamente relevantes, según el criterio del investigador, tales como hipertensión arterial no controlada, insuficiencia cardiaca congestiva de clase NYHA ? III (APÉNDICE 2), angina de pecho inestable o arritmia mal controlada. Infarto de miocardio dentro de los 6 meses previos a la aleatorización.
    10.Cualquier otra enfermedad grave concomitante o disfunción orgánica sistémica que en opinión del investigador comprometería la seguridad de la paciente o interferiría con la evaluación de la seguridad del fármaco analizado.
    11.Cualquier contraindicación a medicamentos orales.
    12.Infección activa por el virus de la hepatitis B (definida por la presencia del Ags del VHB y/o el ADN del VHB), infección activa por el virus de la hepatitis C (definida por la presencia del ARN del VHC) o ser portador conocido del VIH.
    13.Conocimiento o sospecha de abuso de fármacos o de alcohol.
    14.Hipersensibilidad conocida a afatinib, letrozol o a los excipientes de cualquiera de los fármacos del ensayo.
    15.Tratamiento concomitante con un inhibidor potente de P-gp (véase sección 5.5.2).
    16.Cualquier efecto tóxico agudo en curso clínicamente significativo de un tratamiento anticanceroso previo o cualquier complicación persistente de una cirugía previa.
    E.5 End points
    E.5.1Primary end point(s)
    Progression Free Survival (PFS). It is defined as the time from randomization until date of progression (assessed by RECIST) or death due to any cause, whichever occurs first.
    La supervivencia libre de progresión (SLP) se define como el tiempo transcurrido desde la aleatorización hasta la fecha de la progresión (evaluada según los criterios RECIST) o el fallecimiento debido a cualquier causa, lo que antes ocurra.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Disease assessments every 12 weeks until documentation of progressive disease.
    Evaluaciones de la enfermedad cada 12 semanas hasta la documentación de la progresión de la enfermedad .
    E.5.2Secondary end point(s)
    Overall survival (OS), Objective Response rate (OR) and Time to tumor progression (TTP)

    Overall safety profile
    Supervivencia global (SG), tasa de respuestas objetivas (TRO) y tiempo a la progresión tumoral (TP)

    Criterio de valoración : perfil de seguridad global
    E.5.2.1Timepoint(s) of evaluation of this end point
    Overall survival (OS):
    under treatment: every 4 weeks
    after treatment up to documentation of disease progression: every 12 weeks
    after documentation of disease progression up to the end of the study: every 6 months
    Objective response rate and Time to Tumor Progression: every 12 weeks

    Overall safety Profile:
    under treatment: every 4 weeks (Physical examination, vital signs, blood test), every 12 weeks (LVEF)
    after treatment up to documentation of disease progression: every 12 weeks (AE related to the study treatment)
    after documentation of disease progression up to the end of the study: every 6 months (SAE related to the study treatment)
    Supervivencia global (SG):
    Durante el tratamiento: cada 4 semanas
    Después del tratamiento hasta la documentación de progresión de la enfermedad: cada 12 semanas
    Después de la documentación de progresión de la enfermedad hasta el final del estudio: cada 6 meses
    Tasa de respuesta objetiva y tiempo hasta la progresión del tumor: cada 12 semanas

    En general el perfil de seguridad:
    en tratamiento: cada 4 semanas (examen físico, signos vitales, análisis de sangre), cada 12 semanas (FEVI)
    Después del tratamiento hasta la documentación de progresión de la enfermedad: cada 12 semanas (AA relacionado con el tratamiento del estudio)
    después de la documentación de progresión de la enfermedad hasta el final del estudio: cada 6 meses (SAE relacionado con el tratamiento del estudio)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Letrozole alone
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA13
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Bosnia and Herzegovina
    India
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months42
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months42
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 75
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 75
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state65
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 85
    F.4.2.2In the whole clinical trial 150
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    As per protocol the subjects are treated as long as they benefit from the treatment. After the study, the subjects are treated as per standard of care.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation GEICAM (Spanish Breast Cancer Research Group Foundation)
    G.4.3.4Network Country Spain
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-10-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-09-11
    P. End of Trial
    P.End of Trial StatusCompleted
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